At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open Label, Phase II Study of Capecitabine (Xeloda®) as Fluoropyrimidine of Choice in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer Suitable for Treatment With a Fluoropyrimidine-Based Regimen
In Brief
A Phase 2 clinical trial evaluating Cisplatin, Capecitabine, and 3 other interventions for Gastric Cancer. Completed, enrolled 158 participants across 51 sites.
Detailed Summary
This study will assess the safety and efficacy of Xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the chemotherapy regimen used. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Study Details
Timeline
Interventions
80 mg/m2/day, intravenous (IV), every 3 weeks
1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle
50 mg/m2/day, IV, every 3 weeks
60 mg/m2/day, IV, every 3 weeks
625 mg/m2, oral, twice daily per 3-week cycle
130 mg/m2/day, IV, every 3 weeks
60 mg/m2/day, IV, every 3 weeks
825 mg/m2, oral, twice daily for 2 weeks